First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation

An Open-label, Multi-centre Study to Evaluate Efficacy and Safety of Gefitinib as the First-line Treatment for Locally Advanced (IIIB), Metastatic (IV) or Recurrent Pulmonary Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation.

The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.

Study Overview

• Status: Completed
• Conditions: Pulmonary Cancer
• Intervention / Treatment: Drug: Gefitinib

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam-Si, Korea, Republic of
    • Research Site
  • Seoul, Korea, Republic of
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis
• WHO Performance Status 0-2
• No prior chemotherapy, biological or immunological therapy/surgery

Exclusion Criteria:

• Any evidence of clinically active interstitial lung disease
• Newly diagnosed CNS metastases that have not yet been definitively treated with surgery /radiation
• Patients with previously diagnosed and treated CNS metastases or spinal cord compression

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gefitinib; Gefitinib 250mg tablet once daily	Drug: Gefitinib; 250mg tablet oral tablet once daily; Other Names: ZD1839; IRESSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.	Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients. RECIST criteria: CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria	baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	Progression free survival calculated using Kaplan-Meier Product Limit. Median PFS was not able to be calculated because the rate of PFS was below 50% at the end of follow-up period. Therefore, PFS percentage at 4 months is provided.	baseline to 4 months
Overall Survival (OS)	Median Overal survival was not able to be calculated because the rate of OS was below 50% at the end of follow-up period. Therefore, OS percentage at 12 months is provided.	baseline to 12 months
Safety Profile: Participants With Adverse Events	Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.	baseline to end of study

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: HyeJong Yoo, AstraZeneca

Publications and helpful links

General Publications

• Kim DW, Lee SH, Lee JS, Lee MA, Kang JH, Kim SY, Shin SW, Kim HK, Heo DS. A multicenter phase II study to evaluate the efficacy and safety of gefitinib as first-line treatment for Korean patients with advanced pulmonary adenocarcinoma harboring EGFR mutations. Lung Cancer. 2011 Jan;71(1):65-9. doi: 10.1016/j.lungcan.2010.04.005.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: June 26, 2006
• First Submitted That Met QC Criteria: June 26, 2006
• First Posted (Estimate): June 27, 2006

Study Record Updates

• Last Update Posted (Estimate): June 29, 2010
• Last Update Submitted That Met QC Criteria: June 24, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Locally advanced (IIIB) pulmonary adenocarcinoma with EGFR mutation; Metastatic (IV) pulmonary adenocarcinoma with EGFR mutation; Recurrent pulmonary adenocarcinoma with EGFR mutation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Gefitinib
• Other Study ID Numbers: D7913L00056